Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau
The Medical Devices Directorate (MDD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.
MDD ensures that medical devices sold in Canada meet safety, effectiveness and quality requirements. This is done by a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
The term “medical device” covers a wide range of medical instruments used to treat, reduce, diagnose or prevent a disease or abnormal physical condition. Some examples include:
Class I, II, III, IV
There are two pathways for medical device registration in Canada:
Class II license applications: 15 calendar days
Class III license applications: 75 calendar days
Class IV license applications: 90 calendar days
1 year
Labelled in either English or French.
In Canada, maintaining a pharmacovigilance system is imperative to ensure the ongoing monitoring of medicinal products and medical devices, guaranteeing their safe use. Health Canada oversees the Canada Vigilance Program, a robust pharmacovigilance initiative responsible for collecting and evaluating adverse drug reaction reports related to health products.
Individuals, including healthcare professionals, patients/consumers, manufacturers, and distributors, have the obligation to directly submit adverse drug reaction (ADR) reports to Health Canada or Marketing Authorization holders.
The Canada Vigilance Program operates through seven regional offices, serving as regional points of contact for health professionals and facilitating the collection of reports from these regions. Subsequently, these reports are forwarded to the Canada Vigilance National Office for thorough analysis. Complementing these efforts, Canada maintains the Canada Vigilance Online Database, encompassing all suspected adverse drug reaction reports.
As a prominent global player, DDReg recognizes the paramount importance of patient safety across the entire spectrum, from clinical trials to post-marketing surveillance of medicinal products. In alignment with this commitment, our safety services portfolio for Canada encompasses end-to-end pharmacovigilance services.
This includes adverse drug reaction reporting, signal detection and management, aggregate report writing, and the development of customized pharmacovigilance plans/risk management plans, adhering to local requirements and good pharmacovigilance practices.
Before placing a medical device into the market.
Contact us for free consultation: info@omcmedical.co.uk
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.